Label: OB TOWELETTE- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 1, 2009

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  • ACTIVE INGREDIENT

    Benzalkonium chloride .4%
  • PURPOSE

    Antiseptic

  • USE

    Antiseptic to help prevent the risk of infection
  • WARNINGS

    For external use only.

    Do not

    • use in the eyes
    • use as a first aid antiseptic longer than one week
    • apply over large areas of the body

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Stop use and ask a doctor

    if condition persists or gets worse



    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • STORAGE AND HANDLING


  • INACTIVE INGREDIENTS

    fragrance, o-phenylphenol, sodium bicarbonate, water
  • QUESTIONS


  • CARTON INFORMATION

    TRIAD

    Cat. No. 10-5102
    NDC 50730-5102-0

    Obstetrical Antiseptic Towelettes

    Helps prevent the risk of skin infections
    For Professional and Hospital Use Only

    100 towelettes

    carton






  • INGREDIENTS AND APPEARANCE
    OB TOWELETTE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-5102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride.004 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-5102-0100 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/1999
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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